—#93799

Product

Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 12640-01

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K060806
Affected lot / code info: list number 12640-01, lot numbers 682105H and 770815H

Why it was recalled

Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Hospira issued Urgent Device Recall letters dated August 12, 2010 to Hospira's direct accounts, informing them of the potential for under delivery under low rate settings using the affected lots of pump sets. The accounts were instructed to examine their inventory for the affected product, quarantine it immediately, and complete the attached reply form indicating the amount of product being returned, faxing it to Stericycle at 1-877-523-9110. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. Accounts may contact Hospira Customer Care at 1-877-946-7747 or their Hospira Account Manager to obtain replacement product. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187. Customers may contact Stericycle, which is managing this recall, at 877-274-7163 for further information concerning this recall.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.

Timeline

Recall initiated: 2010-08-12
Posted by FDA: 2010-09-29
Terminated: 2012-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93799. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.